Carbon black

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from June 1978 to July 1978

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Carbon black

EC Number:

215-609-9

EC Name:

Carbon black

Cas Number:

1333-86-4

Molecular formula:

C

IUPAC Name:

carbon

Test material form:

solid: nanoform, no surface treatment

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: S. Ivanovas GmbH & Co., Med. Versuchstierzuchten K.G., Kißlegg/Allgäu, Germany
- Age at study initiation: 38 days (male), 42 days (female)
- Weight at study initiation: 100 -105 g
- Fasting period before study: 15-16 hours
- Housing: single, in Makrolon cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 0.5
- Humidity (%): 55 +/- 5
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

IN-LIFE DATES: From: June 1978 To: Jui 1978

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous hydroxypropyl methyl cellulose (0.8%)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: not reported (maximum technically achievable concentration)
- Amount of vehicle (if gavage): 50 mL/kg
- Justification for choice of vehicle:

MAXIMUM DOSE VOLUME APPLIED: not reported

Doses:

8000 mg/kg bw (maximum technically achievable concentration)

No. of animals per sex per dose:

20

Control animals:

no

Details on study design:

TEST ANIMALS: 10 male and 10 female Sprague-Dawley rats, from Ivanovas GmbH & Co., Kisslegg/Allgäu), weight between 100 and 105 g. Age at study begin: 38 days (male animals), 42 days (female animals). Animals were fed standard laboratory diet (Altromin), water was available ad libitum. Animals were held individually in macrolon cages in an air-conditioned room at 22 +/- 0.5 deg centigrade, and a relative humidity of 55% +/- 5%. EXPOSURE TO TEST SUBSTANCE: The test substance was applied via single gavage as suspension in 0.8% aqueous hydroxypropyl methyl cellulose E4M in a constant volumne of 50 mL/kg bw. Food was withdrawn 15-16 hours before administration of the test substance. POST EXPOSURE OBSERVATION PERIOD: 4 weeks. OBSERVATIONS/PARAMETERS: behaviour, food consumption, body weight gain. All animals were necropsied and macroscopically evaluated at the end of the post-observation period.

Statistics:

Not performed

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 8 000 mg/kg bw

Mortality:

There was no mortality.

Clinical signs:

other: There were no clinical signs of toxicity.

Gross pathology:

Findings at necropsy were unremarkable

Other findings:

Post-dose observation time was 4 weeks. There were no effects with regard to the behaviour of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 value in rats is greater than 8000 mg/kg bw (maximum achievable concentration)

Executive summary:

No mortality and no signs of toxicity occured in a OECD 401 guideline study with rats at 8,000 mg/kg bw. Necropsy findings were unremarkable.